Explanation of Claim Types

The claims of each patent in the Orange
Book have been examined, and we have provided our opinion of the category
that a claim should fall into. As we went through the patents, we kept
adding new categories, finally arriving at the following nineteen:

Claim Type

Explanation

Compound

Just the chemical, usually delineated
by its structure

Composition

One or more active ingredients
and a pharmaceutically acceptable carrier

Formulation

Any combination of one or more
active ingredients where something in addition to the presence of the active
ingredients and the carrier is specified. This can be a specific excipient,
or it can be the ratio of two active ingredients, or it can be any other
claim limitation that we feel distinguishes the claim from a composition
claim.

Method of use

A method of using the active
ingredient to treat a disease

Process

Method of making something.
E.g., method of making the active ingredient; method of making a dosage
form; method of preparing a formulation

Product-by-process

Anything where a product (including
an intermediate or excipient) is described by its method of preparation

Device

Anything with “parts,” e.g.,
walls, chambers, etc., such as an osmotic pump dosage form. It of course
also includes more traditional devices, such as spray pumps, syringes,
etc.

Kit

Mainly defined in the claim,
itself, e.g., “a kit comprising . . .”

Intermediate

A chemical used to make another
chemical. DNA is an intermediate when the final product is a protein or
polypeptide.